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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBRACAnalysis CDx®
ApplicantMyriad Genetic Laboratories
320 Wakara Way
Salt Lake Cit, UT 84108
PMA NumberP140020
Supplement NumberS029
Date Received06/04/2024
Decision Date10/04/2024
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of manufacturing site change for BRACAnalysis CDx®
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